A tidal wave of questions floats the need for more upstream automation.
The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.
Both adherent and suspension cell culture approaches have their pros and cons, which must be considered for process development.
In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.
The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
Growing differentiated cells from stem cells may now be a bit easier than before, thanks to the findings from a new study on the production of liver cells. The study, backed by the Centre for Regenerative Medicine and published in Stem Cell Reports, finds that laminins may be a crucial element for the successful clinical-scale production and culture of stem cell therapies. The UK Regenerative Medicine Platform, the European Union Seventh Framework Programme, and the German Federal Ministry of Education and Research funded the research.
The authors present a review of the techniques commonly used for glycosylation analysis.
ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.
Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.
Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.
Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.
Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.
GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.
A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.
The Mobius 2000-L single-use bioreactor from EMD Millipore offers configurable software, hardware, and single-use Flexware assemblies for suspension and adherent cell-culture applications.
Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.
Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.
GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.
Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.
IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.
Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.
Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.
EMD Millipore debuts a new cell-culture media compacting technology that will turn messy, dry powders into granules.
Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
Medicago's new production facility will make plant-based vaccines and therapeutics.
